Actively Recruiting
Acute Immune Modulation by Probiotic Strain Bacillus Coagulans JBI-YZ6.3 (BC4U)
Led by Natural Immune Systems Inc · Updated on 2024-12-31
24
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
Sponsors
N
Natural Immune Systems Inc
Lead Sponsor
J
Jeneil Biotech Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the immediate effects of three different doses of a probiotic strain called Bacillus coagulans JBI-YZ6.3 (BC4U) on immune function compared to a placebo. This clinical proof-of-concept study involves 24 healthy adult participants aged 18 to 75 years. The goal is to understand how the probiotic influences immune status and cytokine levels shortly after intake. Participants will take placebo and three escalating doses of the probiotic — 0 mg (placebo), 100 mg, 200 mg, and 400 mg — each during separate clinic visits spaced at least one week apart for washout. At each visit, blood samples will be collected before the dose and again at 1, 2, and 3 hours after taking the probiotic or placebo. During the study, participants will undergo blood draws to assess immune communication, immune surveillance, cell activation, cell priming, and cytokine profiles. Researchers will monitor these immune responses up to 3 hours after dosing. The study requires participants to maintain consistent diet and lifestyle habits and involves multiple visits over the course of the trial ending in December 2025.
CONDITIONS
Brief Title
Acute Immune Modulation by Probiotic Strain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adults
- Age 18 to 75 years (inclusive)
- Veins easy to see in one or both arms for blood draws
- Willing to comply with study procedures, including maintaining a consistent diet and lifestyle
- Consistent habit of bland breakfasts on clinic visit days
- Abstaining from exercise and nutritional supplements on the morning of visits
- Abstaining from coffee, tea, and soft drinks for at least one hour before visits
- Abstaining from music, candy, gum, and computer/cell phone use during visits
You will not qualify if you...
- Previous major gastrointestinal surgery (minor surgeries like appendix or gall bladder removal allowed)
- Daily use of anti-inflammatory medications
- Experiencing intense stressful events or life changes
- Currently in intensive athletic training (e.g., marathon runners)
- Taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa, or Seroquel
- Having an unusual sleep routine (e.g., graveyard shift work, frequent late nights)
- Unwilling to maintain consistent supplement intake during the study
- Anxiety about blood draws
- Pregnant, nursing, or trying to become pregnant
- Known food allergies related to the study product or placebo
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 7 weeks including washout periods
Participants take placebo and three escalating doses of the probiotic on separate clinic visits, each separated by a 1-week washout period. Blood samples are collected before and up to 3 hours after dosing to assess acute immune effects.
4 clinic visits (in-person)
Trial Site Locations
Total: 1 location
1
NIS Labs
Klamath Falls, Oregon, United States, 97601
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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